#34 - FDA Cutbacks, lymphoma therapies and new AI models

The coffee break biotech roundup, by SomX.

Greetings friends

It has been another jam-packed week in the world of biotech. Allogene's CAR-T therapy shows promise in lymphoma, Ginkgo Bioworks unveils AI model mDD-0 for mRNA engineering, NaturalX launches a bumper €100M fund for European consumer health startups, and the FDA faces major cuts as a result of President Trump’s shake-up of central government.

Happy reading comrades!

Dodo

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Discover 🔍

🐸 Allogene’s phase 1 lymphoma data show CAR-T could ‘leapfrog’ competition (Fierce Pharma): Allogene’s off-the-shelf CAR-T, cema-cel, is showing some serious potential in phase 1 trials. Overall response rate (ORR) and complete response (CR) rate are equal to that of commercially available CAR-Ts, and durability data is excellent – with a progression-free survival of 24 months and “multiple patients in ongoing complete remissions beyond four years”. While Allogene may have had a setback with their leukaemia CAR-T, they might just fast-track their way to the top of the lymphoma scene.

Our take: Just two months ago, Allogene's decision to abandon their leukaemia plans may have signalled the death knell for their CAR-T aspirations, but this latest data drop for lymphoma treatment confirms them as a key competitor in the space. The company is now pinning their hopes on their ALPHA3 phase 2 trial, where they hope to predict and intervene before relapse. Bold aspirations indeed!

🧬 A generative model for complete mRNA sequences that deliver custom therapeutic payloads (Ginko AI): In the crowded AI space, Ginkgo Bioworks has launched mDD-0, a generative AI model for mRNA engineering, which harnesses discrete diffusion techniques to craft novel mRNA sequences. Trained on a huge genomic database spanning hundreds of species, DD-0 churns out mRNA constructs that could pass for the real deal – opening up exciting possibilities for mRNA therapeutics and beyond.

Our take: mDD-0’s training on a diverse genomic dataset is a clever approach to capture nature's time-tested design principles. This biomimetic strategy could yield mRNA sequences that are not only functional, but also potentially more compatible with biological systems – possibly reducing unwanted immune responses or other side effects. But the real test of mDD-0's capabilities will come through experimental validation…we’ll keep our eyes peeled for those results!

🤑 Pharma giant Schwabe unveils €100m fund for European consumer health startups (Sifted): NaturalX Health Ventures is making waves in the European consumer health scene with a fresh €100m fund courtesy of its parent company, pharmaceutical big hitter Schwabe Group. The Berlin-based VC is ready to shake things up, focusing on Series A rounds with juicy €3m-5m cheques for early-stage startups.

Our take: Founder Marvin Amberg is betting big on the consumer health revolution, as individuals increasingly prioritise health as a personal responsibility and status symbol. This mirrors trends observed in the US, where consumer-centric health companies like Hims/Hers and Headspace have flourished. Europe, however, has lagged behind in this space, making this fund a timely intervention to catalyse innovation at scale.

🤖 Reid Hoffman enters the ‘wondrous and terrifying’ world of health care with latest AI startup (CNBC): Tech titan Reid Hoffman is swapping LinkedIn connections for chemical compounds with his latest venture, Manas AI. Teaming up with Pulitzer Prize-winning oncologist Dr. Siddhartha Mukherjee, Manas AI is on a mission to give the sluggish drug discovery process a much-needed adrenaline shot. They're aiming to slash the typical decade-long, billion-dollar drug development marathon into a few-year sprint.

Our take: With $24.6 million in seed funding – and an initial focus on aggressive cancers like prostate cancer, lymphoma and triple-negative breast cancer – Manas is hoping to inject some healthy competition into the AI drug development space. Manas’ approach is not entirely novel, but the combination of Hoffman's tech industry clout and Dr. Mukherjee's oncology expertise could very well create a formidable partnership.

And finally…

✂️ FDA’s head of device safety among employees terminated in ‘challenging’ weekend (STAT News): In a shocking twist, Ross "Rusty" Segan, the FDA's top watchdog for medical device safety, was given his walking papers this weekend. Segan, who barely had time to warm his seat since September, fell victim to the Trump administration's sweeping job cuts. Michelle Tarver, the big boss at the Center for Devices and Radiological Health, dropped the bombshell in a staff email which has left the medical device world spinning!

Our take: The recent termination of Ross Segan and a significant number of FDA staff from the Center for Devices and Radiological Health (CDRH) by the Trump administration is a deeply concerning development that merits serious scrutiny. By removing key personnel – including the head of medical device safety – the administration is potentially compromising the agency's ability to perform its vital regulatory functions, which could have huge ramifications on patient safety. Dodo will be keeping a close eye on this developing story.

Tune in

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🧠NIH funding cuts, a US brain drain, and bold claims from AI drug developers
NIH budget cuts spark academic panic while AI drug discovery hype faces scrutiny: this episode dives into the double whammy hitting U.S. biomedical research, from slashed university overhead budgets to overblown AI promises in pharma.

🔬Looking at the Promise of GLP-1 Agonists Beyond Obesity
Coya Therapeutics is betting big on a triple threat: combining low-dose IL-2, GLP-1 agonists, and other agents to tackle inflammation in neurodegenerative and autoimmune diseases. CEO Arun Swaminathan discusses leading the charge in this ambitious "pipeline-in-a-product" strategy.

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